Over the last 6 months I have spent a lot of time talking to various clients about transforming their Regulatory Affairs organization in terms of Processes, Data and Systems. Many organizations are looking for a holistic approach to transformation, across all the three aspects and additionally assure better user experience. The following are the themes that are emerging, with regards to challenges faced by Regulatory Affairs organizations:
- Functional, Geographical and Departmental silos creating hurdles for x-functional collaboration
- Fragmented systems and tools, a situation that is a result of efforts to build best-of-the-breed platforms combined with legacy systems that leave the burden of end-to-end integration to the pharma companies
- Need for continuous upgrade / enhancements of various tools to keep up with regulatory and technology changes which create a need for projects all the time disrupting business and IT teams
- Inefficient business processes and data governance that is either a result of trying to make up for lack of features in the chosen systems & tools or due to #1 above
- Finally, lack of human centered design of systems leading to lower of adoption, process inefficiencies, compliance issues etc.
In order to overcome these challenges, many organizations have prioritized programs to find a platform that can become their Regulatory Affairs Management platform of the future. Having spent time working with various pharma companies, tool vendors and industry experts in Regulatory Affairs, I have come to the conclusion that the following five platforms are leading the pack in terms of becoming the platform of choice for end-to-end Regulatory Information Management. Also, I know of at least one Top 20 Pharma, Biotech, Med Devices customer that has selected one of these platforms to invest in and make it their platform of the future.
- AMPLEXOR LS Suite
- ArisGlobal LifeSphere Regulatory
- OpenText Documentum D2 LS Suite
- PAREXEL Regulatory Cloud and
- Veeva Vault RIM
Some of the other notable names that are either being considered by smaller pharma, generics companies etc.:
- DXC Regulatory Suite
- Mission 3
If the challenges I have listed in this post resonate with you then I strongly recommend considering one of the top 5 platforms listed above as a means to address these challenges. While platform is not a silver bullet that can solve all the challenges listed, it is definitely a good starting point. Along with the platform, “Business Process Transformation” and “Innovation” should be high on the agenda to make a difference to your Regulatory Affairs staff and help them improve their cycle times and in turn faster approvals to your products. In a subsequent post, I will look at the criteria to be used in evaluating the right platform for your needs as well as elaborate on the need for Business Process Transformation and opportunities for innovation in Regulatory Affairs.
For as long as I have known the regulatory tools market space, it has been much more fragmented that it’s peer business functions such as Clinical and Safety. If you take the Regulatory Affairs value chain from Strategy / Submission Planning all the way through Archival, many sponsors use different products / platforms / tools for different functions. Typically you would see a mix of Excel/Spreadsheets to established tools for regulatory document & content management as well as publishing, submissions and archival. This is in contrast with Clinical and Regulatory space where you would typically find 2, if not 3 platforms that can cater to a major portion of the value chain. More than Clinical I would say Safety is probably a better in example to highlight this situation where you’d most likely find 2 products ruling the roost in Oracle Argus and Aris Global’s ARISg (LifeSphere Safety).
This situation in Safety platforms space was not achieved overnight but rather over 5 – 7 years through market consolidation. Oracle essentially bought off all the other reputable and competing tools in the market leaving only ARISg to compete with. Off late there has been a similar trend in the regulatory market with some of the niche tool providers like Octagon, ISI etc. being acquired by larger players like PAREXEL, Accenture, and CSC. While this has resulted in consolidation of the tools/platforms under a smaller set of vendors, these tools still need lot of integration to make them work together. There are vendors like Veeva (Veeva Vault RIM) that have taken a different approach to this problem and have reached a point where they can claim more cohesive platform that integrates out-of-the-box, and as is the case with Safety platforms, caters to majority of the functions in Regulatory Affairs value chain. However the jury is still out whether some of these platforms deliver the value they are expected to since the adoption has just begun and long term use is still not proven.
With the advent of Cloud solutions and adoption becoming a reality in Life Sciences R&D, even though it is much slower as opposed to other industries and even departments within Life Sciences for regulatory reasons, platforms on the cloud with coverage across the Regulatory Affairs value chain can get us closer to RPaaS. The reality of budget challenges across many Life Sciences companies is going to force the issue. For Platform vendors like Veeva and Aris Global the key is interest and willingness to invest by their clients. It will not be a win-win proposition unless each party can look forward to cost reduction, productivity improvement, technology currency and regulatory compliance through these platforms.